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COVID-19 (SARS-CoV-2) in Urine and Semen

COVID-19 (SARS-CoV-2) in Urine and Semen: Qualitative and Quantitative Analyses and Evaluation of STD, Sexual Function, Fertility and Urinary Function

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04446169
Enrollment
43
Registered
2020-06-24
Start date
2020-06-27
Completion date
2021-09-02
Last updated
2021-10-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

SARS-CoV 2, Semen, Sexual Function and Fertility Disorders, Urinary Function Disorders, Urine

Keywords

SARS-CoV 2, Sexual Function, Fertility, Urine, Semen

Brief summary

This study is part of the current global emergency scenario due to infection with Coronavirus, SARS-CoV-2 as indicated by the international taxonomy. Study aim is to investigate the possibility of the presence of the virus within the seminal fluid and in the urine of infected patients, both during the acute phase and remotely. Current evidences show that Coronaviruses can be present inside the testicle and sperm in other species, such as in feline and avian models. In human beings, current researches have mixed results regarding the presence of SARSCoV-2 in urine, as several studies with a large sample found no traces of the same with Real-Time Reverse method Transcriptase - Polymerase Chain Reaction or with method of nucleic acid amplification. By contrast, in just over 6% of 58 patients with Real Time Polymerase Chain Reaction method have found the presence of SARS-CoV-2 in the urine, even at a distance from the last negative nasopharyngeal swab. Given the topicality of the problem, our study has the objective of specifically researching the presence and possible persistence over time of SARS-CoV-2 in seminal fluid and urine. A saliva sample will also be collected as a control. At the moment there are no studies in literature that tested this possibility. If confirmed, it would lead to find out another potential method of transmission, the sexual one, in asymptomatic patients or apparently no longer infectious with negative buffer. The rationale for our study is the evidence that in other species this type of transmission by coronaviruses is possible and that at present it has not been verified in mankind. The relevance of the study would be both in the case of a negative result, as the first study in its generally, both in the case of a positive result, due to the possibility of introducing new prevention measures in the long run.

Detailed description

This study is part of the current global emergency scenario due to infection with Coronavirus, SARS-CoV-2 as indicated by the international taxonomy. Study aim is to investigate the possibility of the presence of the virus within the seminal fluid and in the urine of infected patients, both during the acute phase and remotely. Current evidences show that Coronaviruses can be present inside the testicle and sperm in other species, such as in feline and avian models. In human beings, current researches have mixed results regarding the presence of SARSCoV-2 in urine, as several studies with a large sample found no traces of the same with Real-Time Reverse method Transcriptase - Polymerase Chain Reaction or with method of nucleic acid amplification. By contrast, in just over 6% of 58 patients with Real Time Polymerase Chain Reaction method have found the presence of SARS-CoV-2 in the urine, even at a distance from the last negative nasopharyngeal swab. Given the topicality of the problem, our study has the objective of specifically researching the presence and possible persistence over time of SARS-CoV-2 in seminal fluid and urine. A saliva sample will also be collected as a control. At the moment there are no studies in literature that tested this possibility. If confirmed, it would lead to find out another potential method of transmission, the sexual one, in asymptomatic patients or apparently no longer infectious with negative buffer. According to results obtained, follow up will be tailored to patients (assessment for COVID 19 infections and/or further analysis/folliow-up in case of abnormal findings) The rationale for our study is the evidence that in other species this type of transmission by coronaviruses is possible and that at present it has not been verified in mankind. The relevance of the study would be both in the case of a negative result, as the first study in its generally, both in the case of a positive result, due to the possibility of introducing new prevention measures in the long run.

Interventions

DIAGNOSTIC_TESTSARS-CoV 2 RNA PCR Urine

Search for SARS-CoV 2 RNA in urine through PCR

DIAGNOSTIC_TESTSARS-CoV 2 RNA PCR Semen

Search for SARS-CoV 2 RNA in Semen through PCR

DIAGNOSTIC_TESTSemen Qualitative Analysis

Search for Semen Alterations in patients with past SARS-CoV 2 infection

DIAGNOSTIC_TESTIIEF-5 questionnaire

IIEF-5 assessment in patients with past SARS-CoV 2 infection

DIAGNOSTIC_TESTMale Sexual Health Questionnaire (MSHQ)

Male Sexual Health Questionnaire (MSHQ) assessment in patients with past SARS-CoV 2 infection

DIAGNOSTIC_TESTIPSS questionnaire

IPSS assessment in patients with past SARS-CoV 2 infection

DIAGNOSTIC_TESTSECRET questionnaire

SECRET questionnaire assessment in patients with past SARS-CoV 2 infection

DIAGNOSTIC_TESTInterleukin assessment in semen

Assessment of Interleukin presence and quantitative analysis in semen, to study if a previous inflammation/infection due to SARS-CoV 2 in testis was present

Sponsors

Azienda Ospedaliero-Universitaria Careggi
CollaboratorOTHER
University of Florence
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
MALE
Age
18 Years to 80 Years

Inclusion criteria

* Male Sex * Age\>18 years * Will to participate to the study * Documented past infection for SARS-CoV2 (Nasopharyngeal swab positive for SARS-CoV2 RNA) * Current negative infection for SARS-CoV2 (Two negative Nasopharyngeal swab for SARS-CoV2 RNA, done following WHO guidelines)

Exclusion criteria

* Age more than 80 years old * Anejaculation * Patient's will

Design outcomes

Primary

MeasureTime frameDescription
Semen quantitative and qualitative analysisEnrollmentSpermiogram done following WHO guidelines and criteria
SARS-CoV 2 presence in semenEnrollmentSARS-CoV 2 RNA PCR in semen
SARS-CoV 2 presence in urineEnrollmentSARS-CoV 2 RNA PCR in urine
Inflammation in SemenEnrollmentInterleukin quantitative analysis in Semen, to assess if past inflammation due to SARS-CoV 2 Infection was present

Secondary

MeasureTime frameDescription
Sexual HabitsEnrollmentSExual Chronicle REcording Table (SECRET) questionnaire administration Questionnaire helps to assess the sexual habits of individuals
Urinary functionEnrollmentInternational Prostate Symptom Score (IPSS) questionnaire administration Score range from 0 to 35. Higher scores mean worst urinary function
Erectile FunctionEnrollmentInternational Index of Erectile Function (IIEF-5) questionnaire administration. Score range from 0 to 25. Higher scores mean good erectile function
Sexual and Ejaculatory FunctionEnrollmentMale Sexual Health Questionnaire Short Form (MSHQ-SF) admnistration Higher scores mean better sexual and ejaculatory function

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026